Efficacy of XP20B Following Bunionectomy Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00655291
Recruitment Status : Completed
First Posted : April 9, 2008
Last Update Posted : October 8, 2008
Information provided by:
Xanodyne Pharmaceuticals

Brief Summary:
The purpose of this study is to determine if XP20B is an effective treatment for the relief of pain following bunionectomy surgery.

Condition or disease Intervention/treatment Phase
Acute Pain Drug: XP20B Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study of the Analgesic Efficacy of XP20B in Subjects With Pain Following Bunionectomy Surgery
Study Start Date : April 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Arm Intervention/treatment
Placebo Comparator: A Drug: Placebo
Experimental: B Drug: XP20B

Primary Outcome Measures :
  1. Average pain over a fixed dosing period [ Time Frame: Multiple-day ]

Secondary Outcome Measures :
  1. multiple pain assessments over a fixed dosing period [ Time Frame: Multiple-day ]
  2. Rescue medication use [ Time Frame: Multiple-day ]
  3. Safety evaluations [ Time Frame: Multiple-day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • having undergone bunionectomy surgery
  • having achieved the requisite level of pain

Exclusion Criteria:

  • pregnant or lactating
  • history of substance abuse
  • clinically significant condition or lab abnormality
  • taken any prohibited medications
  • gastrointestinal bleeding or history of

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00655291

United States, California
Investigatve Site
Anaheim, California, United States, 92810
United States, Maryland
Investigative Site
Owings Mills, Maryland, United States, 21117
United States, Texas
Investigative Site
Austin, Texas, United States, 78705
Investigative Site
Houston, Texas, United States, 78705
Investigative Site
San Marcos, Texas, United States, 78666
United States, Utah
Investigative Site
Salt Lake City, Utah, United States, 84117
Sponsors and Collaborators
Xanodyne Pharmaceuticals
OverallOfficial: Keith Moore, PharmD Xanodyne Pharmaceuticals

Responsible Party: Caroline Masoner/Clinical Trial Manager, Xanodyne Pharmaceuticals Identifier: NCT00655291     History of Changes
Other Study ID Numbers: XP20B-301
First Posted: April 9, 2008    Key Record Dates
Last Update Posted: October 8, 2008
Last Verified: October 2008

Keywords provided by Xanodyne Pharmaceuticals:

Additional relevant MeSH terms:
Acute Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms